Syringe Adapter with Cap

ABSTRACT

A syringe adapter is provided. The adapter includes a housing having a first end and a second end positioned opposite the first end. The first end of the housing has a connector configured to be secured to a syringe barrel. The adapter also includes a cannula positioned within the housing and a seal arrangement including a membrane or septum positioned within the housing and movable within the housing, the seal arrangement comprising a membrane. The assembly can also include a protective cap having a first open end and a second closed end. The protective cap can be connected to the housing via a snap fit and can be configured to receive the second end of the housing.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application Ser.No. 62/447,024, filed Jan. 17, 2017, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a syringe adapter for connecting asyringe to another medical device or fluid container and, moreparticularly, to a syringe adapter including a housing formed from twoconnected portions or pieces.

Description of Related Art

Healthcare clinicians, such as pharmacists and nurses, can be subject toacute and long term health risks as a result of repeated exposure todrugs or solvents, which may escape into the air during drugpreparation, drug administration, and other similar handling activities.For example, when performing infusions, it is often necessary to injecta drug or other medical substance into an infusion fluid inside aninfusion bag or other infusion fluid container. This injection is oftenperformed by penetrating a septum or other fluid barrier of an injectionport on the infusion bag or on the infusion fluid line with a needle ofa syringe filled with the medical fluid in question. Before penetratingthe septum, it may also be necessary to transfer the medical fluid froma vial to a syringe and then from the syringe to the container. In eachof these steps, the clinician or care provider may be exposed to themedical fluid resulting in contamination from, for example, vaporizedmedical fluids or from contaminants released as an aerosol. For example,contamination may occur by breathing the vaporized or aerosolcontaminates into the lungs. Contamination may also occur when vaporizedor aerosol contaminants condense on and then penetrate the clinician'sor care provider's skin. In some instances, such condensed contaminatesmay even penetrate protective gloves.

Unfortunately, exposure to contaminants may, on a long term basis, giverise to unacceptably high concentrations of medicament or contaminantsin the clinician or care provider's blood or body tissue. Risk ofcontamination is increased due to the many transferring steps betweencontainers which must occur during preparation of complex infusions. Forthese reasons, closed system transfer devices (CSTDs) have beendeveloped to ensure that the medicament is contained in the transferdevice during transfer of the medicament. A CSTD generally includes asyringe adapter for connection to a syringe and another adapter (oftenreferred to as a patient connector) for connection to a vial, a secondsyringe, a fluid container, or a conduit providing fluid access to thepatient's circulatory system. In use, the clinician or care provider mayreconstitute a powdered or lyophilized compound with saline or someother reconstitution medium by attaching the syringe to the vial viaconnection of the respective adapters. The drug is then reconstituted byinjecting fluid from the syringe, through the respective adapters, andinto the vial. In some instances, the reconstituted infusion may then beaspirated into the syringe. After aspiration, the adapters can bedisconnected from one another. The clinician or care provider may thenattach the syringe to another adapter to transfer fluid from the syringeto a fluid conduit or patient delivery device, such as an IV line orsyringe, for administration to the patient. In one or more of theseconnecting steps, the clinician may need to disinfect portions of theadapter(s) to ensure a safe connection therebetween.

In view of the multiple connections that must be performed duringreconstitution of a drug or therapeutic agent, devices and assemblieswhich assist clinicians in preparing adapters for connection with oneanother and/or with a patient line are needed. The syringe adapter, cap,and assembly disclosed herein are configured to address these issues.

SUMMARY OF THE INVENTION

According to an aspect of the disclosure, a syringe adapter is provided.The syringe adapter includes: a housing having a first end and a secondend positioned opposite the first end. The first end of the housing caninclude a connector configured to be secured to a syringe barrel. Theadapter also includes a cannula positioned within the housing and a sealarrangement including a membrane positioned within the housing andmovable within the housing, the seal arrangement comprising a membrane.The syringe adapter also includes a protective cap having a first openend and a second closed end, which can be connected to the housing via asnap fit to receive the second end of the housing.

In some examples, the protective cap can include an annular ringextending radially inward and the housing can define one or morerecesses or protrusions positioned to engage the annular ring to formthe snap fit. Alternatively, the protective cap can include one or moreprojections extending radially inward and positioned to engage one ormore recesses or protrusions of the housing to form the snap fit.

In some examples, the protective cap includes a main body and a flangeextending radially outward from the main body of the protective cap.Optionally, the main body includes an annular shoulder on a radiallyinward side thereof positioned such that the second end of the housingcontacts the shoulder when the adapter is mounted to the cap.

According to another aspect of the disclosure, a syringe adapterincludes a housing having a first end and a second end positionedopposite the first end. The first end of the housing can have aconnector configured to be secured to a syringe barrel. The adapter alsoincludes a cannula positioned within the housing and a seal arrangementincluding a membrane positioned within the housing and movable withinthe housing. The adapter also includes a protective cap having a firstopen end and a second end positioned opposite the first end. Theprotective cap can have a restriction member configured to engage aportion of the seal arrangement to prevent movement of the sealarrangement within the housing.

In some examples, the restriction member can include a tubular supportextending proximally from a base portion of the protective cap, whichcan include a central channel extending between the open first end andthe open second end of the protective cap.

In some examples, the second end of the protective cap can include aremovable cover having an open position and a closed position. When theremovable cover is in the open position, a portion of the membrane ofthe seal arrangement can be accessible via the second end of theprotective cap. When the removable cover is in the closed position, themembrane of the seal arrangement can be inaccessible via the second endof the protective cap.

In some examples, the removable cover can include a living hinge toallow the removable cover to move between the open position and theclosed position. The removable cover can further include a protrudinglatch configured to engage a radially outer portion of the protectivecap to maintain the cover in the closed position. For example, theremovable cover can include a first end pivotally connected to theprotective cap and a second end opposite the first end, such that thelatch extends from the second end of the cover. When in the openposition, a swab is capable of being inserted through the open distalend of the protective cover for disinfecting at least a portion of theseal arrangement.

In some examples, the seal arrangement can include a collet thatreceives the membrane, positioned such that the restriction memberengages a portion of the collet to restrict radial movement of thecollet thereby preventing movement of the collet within the housing.Optionally, the protective cap can be connected to the housing via asnap fit and can receive the second end of the housing.

In some examples, the protective cap comprises an annular ring extendingradially inward. In that case, the housing can define one or morerecesses or protrusions and the annular ring of the protective cap canengage the one or more recesses or protrusions to form the snap fit.

In some examples, the protective cap can include one or more projectionsextending radially inward. In that case, the housing can define one ormore recesses or protrusions and the one or more projections of theprotective cap can engage the one or more recesses or protrusions of thehousing to form the snap fit.

In some examples, the restriction member can include a tubular body. Thetubular body of the restriction member can receive a disinfecting pad.

According to another aspect of the disclosure, a protective capconfigured to be removably mounted to a syringe adapter is provided. Thecap can include an annular body with a proximal portion configured toengage the syringe adapter, a distal base portion, and an annularsidewall extending therebetween. The cap can further include arestriction member connected to and extending proximally from the baseportion of the annular body. The restriction member can include acentral channel extending between an open proximal end and an opendistal end thereof. The cap can further include a cover connected to thebase portion of the annular body. The cover can be transitionable from aclosed position in which it covers the distal open end of the centralchannel and an open position in which a swab is capable of beinginserted through the open distal end of the central channel fordisinfecting an interior of the syringe adapter.

These and other features and characteristics of the present invention,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and the claims, the singular form of “a”, “an”, and“the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of an assembly including a syringe adapter andcap according to an aspect of the present disclosure;

FIG. 2A is a cross-sectional view of the syringe adapter of FIG. 1 takenalong line 2A-2A;

FIG. 2B is an enlarged cross-sectional view of the portion of thesyringe adapter of FIG. 2A enclosed by shape 2B;

FIG. 3A is an enlarged cross-sectional view of a portion of the syringeadapter of FIG. 2A enclosed by shape 3A;

FIG. 3B is a cross-sectional view of another portion of the syringeadapter of FIG. 2A;

FIG. 4A is a front view of a first portion of a housing of the syringeadapter of FIG. 1;

FIG. 4B is a bottom view of the first portion of the syringe adapterhousing of FIG. 4A;

FIG. 5A is a perspective view of a second portion of the housing of thesyringe adapter of FIG. 1;

FIG. 5B is a perspective view of a cross section of the second portionof the syringe adapter housing of FIG. 5A;

FIG. 6 is an exploded perspective view of the housing of the syringeadapter of FIG. 1;

FIG. 7 is an exploded perspective view of another embodiment of ahousing of a syringe adapter;

FIG. 8 is an exploded perspective view of another embodiment of ahousing of a syringe adapter;

FIG. 9A is a front view of a protective cap for a syringe adapter,according to an aspect of the disclosure;

FIG. 9B is a cross-sectional view of the protective cap of FIG. 9A takenalong line 9B-9B;

FIG. 9C is a perspective view of the protective cap of FIG. 9A;

FIG. 10 is a perspective view of another embodiment of a protective capaccording to an aspect of the disclosure;

FIG. 11A is a cross-sectional view of a syringe adapter mounted to theprotective cap of FIG. 9A;

FIG. 11B is an enlarged portion of the cross-sectional view of FIG. 11Aenclosed by shape 11B;

FIGS. 12A-12C are front views of other embodiments of a second portionof a syringe adapter according to aspects of the disclosure;

FIG. 13A is a front view of another embodiment of a protective cap for asyringe adapter according to an aspect of the disclosure;

FIG. 13B is cross-sectional view of the protective cap of FIG. 13A takenalong line 13B-13B;

FIG. 14A is a cross-sectional view of a syringe adapter mounted to theprotective cap of FIG. 13A;

FIG. 14B is a cross-sectional view of the portion of the adapter and capof FIG. 14A enclosed by shape 14B;

FIG. 15A is a schematic drawing of a swab prior to insertion into theprotective cap of FIG. 13A according to an aspect of the disclosure;

FIG. 15B is a schematic drawing showing the swab of FIG. 15A insertedinto the open cap;

FIG. 16A is a front view of a syringe adapter mounted to anotherembodiment of a protective cap according to an aspect of the disclosure;

FIG. 16B is a cross-sectional view of the syringe adapter and cap ofFIG. 16A taken along line 16B-16B;

FIG. 17A is a front view of another embodiment of a protective cap for asyringe adapter according to an aspect of the disclosure; and

FIG. 17B is a cross-sectional view of the protective cap of FIG. 17Ataken along line 17B-17B and connected to a syringe adapter.

DESCRIPTION OF THE INVENTION

The illustrations generally show preferred and non-limiting aspects ofthe systems and methods of the present disclosure. While thedescriptions present various aspects of the devices, it should not beinterpreted in any way as limiting the disclosure. Furthermore,modifications, concepts, and applications of the disclosure's aspectsare to be interpreted by those skilled in the art as being encompassedby, but not limited to, the illustrations and descriptions herein.

Further, for purposes of the description hereinafter, the terms “end”,“upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”,“bottom”, “lateral”, “longitudinal”, and derivatives thereof shallrelate to the disclosure as it is oriented in the drawing figures. Theterm “proximal” refers to the direction toward the center or centralregion of the device. The term “distal” refers to the outward directionextending away from the central region of the device. However, it is tobe understood that the disclosure may assume various alternativevariations and step sequences, except where expressly specified to thecontrary. It is also to be understood that the specific devices andprocesses illustrated in the attached drawings, and described in thefollowing specification, are simply exemplary aspects of the disclosure.Hence, specific dimensions and other physical characteristics related tothe aspects disclosed herein are not to be considered as limiting. Forthe purpose of facilitating understanding of the disclosure, theaccompanying drawings and description illustrate preferred aspectsthereof, from which the disclosure, various aspects of its structures,construction and method of operation, and many advantages may beunderstood and appreciated.

According to an aspect of the disclosure, a syringe adapter forconnecting a syringe to another medical device or fluid container isprovided. The medical device can be, for example, a patient line, vialadapter, fluid container, or injector. In other examples, the containercan be a medical vial, syringe barrel, IV bag, or similar container forholding a fluid to be administered to a patient. The syringe adapter canbe used to facilitate closed transfer of fluids between the syringe andmedical device or fluid container. The syringe adapter can include ahousing formed from a first portion, such as a first grip portion,inserted into a second portion, such as a second grip portion. The firstportion can be connected to the second portion by an axial interferenceand/or a radial interference. Axial interference can refer toengagements between structures of the first portion of the housing andthe second portion of the housing which prevent or inhibit eitherpulling the respective portions of the housing away from one another(e.g., disconnecting the portions of the housing) and/or pushing thefirst portion of the housing farther into the second portion of thehousing. For example, axial interference can refer to situations wherethe first portion is essentially locked to the second portion to preventaxial movement of the first portion relative to the second portion. In asimilar manner, radial interference can refer to structures that preventor inhibit twisting of the portions of the housing relative to oneanother. A syringe adapter including both axial and radial interferencestructures, in combination, helps to more securely lock the portions ofthe housing in place.

According to another aspect of the disclosure, a protective cap for asyringe adapter is provided. An exemplary syringe adapter that can beused with the protective cap is described in United States Patent Appl.Pub. No. 2015/0297454, which is incorporated by reference herein in itsentirety. The cap is configured to allow a user to disinfect an interiorof the syringe adapter without removing the cap therefrom. For example,the cap can be configured to allow a user to insert a swab (e.g., acotton swab immersed in a disinfecting agent, such as isopropyl alcohol)to disinfect an interior of the adapter without removing the cap fromthe adapter. In some examples, the cap can include a cover including adoor or window configured to be opened by the user to allow the user toaccess the interior of the syringe adapter. In other examples, the capcan include a disinfecting swab or pad mounted thereto. The swab or padcan be positioned to be inserted into the interior of the syringeadapter when the cap is removably mounted to the adapter.

With reference to FIG. 1, an exemplary syringe adapter assembly 100 forestablishing fluid communication between a syringe (not shown) and aconnector (referred to hereinafter as “a patient connector”) mounted toa patient line or container is illustrated. The assembly 100 may also beutilized in connection with other components of a fluid transfer systemand/or a closed system transfer device including, but not limited to, avial adapter, an IV bag spike, and an IV line. The assembly 100 caninclude a syringe adapter 110 and a protective cap 10. The syringeadapter 110 generally includes a housing 112 defining an interior 114(shown in FIGS. 2A and 2B). The housing 112 includes a first or proximalend 116 configured to be directly or indirectly mounted to the syringeand an open second or distal end 118. The syringe adapter 110 caninclude a syringe connector 120 disposed at the proximal end 116 thereofand configured to engage the syringe. For example, the syringe connector120 can include a syringe port 122, such as a luer connector or threadedconnector, configured to engage a corresponding structure of thesyringe.

In some examples, the syringe adapter 110 is configured to be removablymounted to a protective cap 10 by, for example, pressing the open distalend 118 of the adapter housing 112 into an open proximal end 12 of thecap 10. For example, the housing 112 can be snap-fit into the cap 10. Asdiscussed herein, the cap 10 can include various locking and/orattachment structures for maintaining the connection between the adapter110 and the cap 10. In some examples, the cap 10 can be configured topartially enclose the open distal end 118 of the housing, for example,to prevent contamination of the adapter housing 112. In some examples,the cap 10 can be transitioned to an open position to allow a user toaccess the interior 114 of the syringe adapter 110 without removing thecap 10 therefrom.

Exemplary Syringe Adapter

FIGS. 1-6 show aspects of an exemplary syringe adapter 110 which can beused with the protective cap 10. As shown in FIG. 2A, the syringeadapter 110 can include a needle cannula 124 mounted to and extendingdistally from the connector 120 into the interior 114 of the housing112. As shown in FIGS. 2A and 2B, the adapter 110 also includes a sealarrangement, generally denoted by 126, including a socket or collet 128slidably mounted into the interior 114 of the housing 112. The collet128 is movable through the interior 114 of the housing 112 between adistal or pre-use position (shown in FIGS. 2A and 2B) and a proximal orin-use position. The seal arrangement 126 also includes a pierceablemembrane or septum 130 mounted to the collet 128. When the collet 128 isin its distal or pre-use position, a distal tip 132 (shown in FIG. 2A)of the cannula 124 is entirely enclosed by the septum 130 for preventingcontamination prior to use. The collet 128 includes a distal flange 134and legs 136 configured to grasp a portion of the patient connector (notshown) or another adapter to mount the syringe adapter 110 thereto. Insome examples, the flange 134 and/or collet legs 136 can be radiallyinwardly biased to grasp the patient connector. When the patientconnector is inserted in the open distal end 118 of the adapter 110, theflange 134 and/or legs 136 are pushed radially outward to a grip orrecessed position in the direction identified by arrows D1 in FIG. 2B.

In use, once the patient connector is mounted to the distal end 118 ofthe adapter 110, the adapter 110 is activated by moving the collet 128from the distal or pre-use position (shown in FIGS. 2A and 2B) to theproximal or use position. Moving the collet 128 in the proximaldirection causes the distal tip 132 of the needle cannula 124 to piercethe septum or seal 130 thereby bringing the needle cannula 124 intocontact with the patient connector or another adapter. Continuedproximal movement of the collet 128 can bring the needle cannula 124into fluid connection with another container or medical device mountedto the patient connector or adapter, thereby establishing fluidcommunication between the syringe and the container or medical devicethrough the syringe adapter 110.

With reference again to FIGS. 1-6, the adapter housing 112 can be formedfrom two or more portions mounted together to enclose the interior 114.For example, the housing 112 can include a first portion 138 insertedinto and/or connected to a second portion 140. In some examples, thefirst portion 138 of the housing 112 can include a grip arrangement 142(shown in FIGS. 1 and 2A), which is shown as two pairs of ellipticalrecesses 144 (shown in FIGS. 1 and 2A). Other suitable grip arrangementsmay also be utilized for facilitating holding and/or manipulating theadapter 110.

In some examples, the first portion 138 of the housing 112 can beconnected to the second portion 140 via axial and radial interferencebetween the first portion 138 and the second portion 140 to effectivelylock the portions 138, 140 together. With specific reference to FIGS.2B, 3A, 3B, 5A, and 5B, in some examples, the second portion 140includes an annular triangular interface, generally shown as 146, whichengages the first portion 138 to form the axial interference. Theannular triangular interface 146 can include a pointed end 148 and aradially inwardly directed sloped annular surface 150 extendingtherefrom. The annular triangular interface 146 is configured to pressinto the first portion 138 of the housing 112 to lock the portions 138,140 together. In some instances, the annular triangular interface 146 ispositioned to press into a corresponding annular planar interface 152(shown in FIGS. 2B, 3A, and 3B) of the first portion 138. The planarinterface 152 can extend about perpendicularly to a longitudinal axis Lof the housing 112. For example, the annular triangular interference canpress or bite into the planar interface to form a suitable connectiontherewith.

In one example, an engagement between opposing bulbous portions orprotrusions extending distally from the first portion 138 and proximallyfrom the second portion 140 may also contribute to the axialinterference, as shown in FIGS. 3A and 3B. For example, the secondportion 140 of the housing 112 can include a bulbous portion orprotrusion 154 configured to engage a corresponding shelf or ledge 156of the first portion 138. The protrusion 154 of the second portion 140can be a radially inwardly extending structure positioned at a proximalend 141 of the second portion 140. In some examples, the protrusion 154can be radially inwardly biased against the ledge 156 to lock the firstportion 138 of the housing 112 to the second portion 140. Contactbetween the protrusion 154 and ledge 156 prevents or make it moredifficult for a user to pull the first portion 138 away from and/or outof the second portion 140.

With specific reference to FIGS. 2B, 3A, 3B, 4A and 4B, the firstportion 138 of the housing 112 can further include a plurality ofprojections 158 configured to engage the second portion 140 to providethe radial interference between the first portion 138 and the secondportion 140. For example, as shown in FIGS. 3A and 3B, the projections158 can bite or press into the inner surface of the second portion 140to lock the portions 138, 140 together and, in particular, to prevent orrestrict twisting of the first portion 138 relative to the secondportion 140. In some examples and as shown in FIGS. 4A and 4B, theprojections 158 can be spaced apart around a circumference of the firstportion 138. The projections 140 may extend radially outward from thefirst portion 138 and, for example, can be configured to engage acorresponding inner vertical surface 160 of the second portion 140. Insome examples, the projections 158 can be longitudinally extendingridges spaced equidistantly about the circumference of the first portion138. In other examples, the projections 158 can be semi-spherical,cylindrical, pyramid shaped, or any other appropriate shape forcontacting the second portion 140 of the housing 112. In other examples,the first portion 138 can be provided with an undulating surface forimparting variable contact with the vertical cylindrical surface 160 ofthe second portion 140 to lock the first portion 130 to the secondportion 132.

With reference to FIGS. 6-8, additional embodiments of the secondportion 140 configured to be mounted to the first portion 138 are shown.In the embodiments of FIGS. 6-8, the proximal end 141 of the secondportion 140 is shaped to produce uneven distribution of stress betweenthe first portion 138 and the second portion 140 when the second portion140 is mounted to the first portion 138 in the direction of arrow A1.For example, the second portion 140 can include a plurality of teeth 162extending axially from the proximal end 141 of the second portion 132.The plurality of teeth 162 are configured to engage the first portion138 of the adapter housing to provide the axial interference. Forexample, the plurality of teeth 162 may press into and/or deform theplanar surface 152 of the first portion 138 to form a suitableengagement therebetween. In some examples, as shown in FIGS. 6 and 7,the plurality of teeth 162 can be spaced apart around the annularproximal end 141 of the second portion 140 and, for example, can beseparated by a substantially planar surface or by a surface that issloped radially inwardly toward a longitudinal axis L of the housing. Inother examples, as shown in FIG. 8, the plurality of teeth 162 can beconnected together around the annular proximal end 141 of the secondportion 140. In this configuration, as shown in FIG. 8, the annularproximal end 141 of the second portion does not include any flat orplanar regions and, instead, is formed from alternating upwardly slopedand downwardly sloped surfaces around the annular proximal end 141 asshown in FIG. 8.

Exemplary Protective Cap

Examples of a protective cap, which can be mounted to the distal end 118of the housing 112 and which can be removed from the syringe adapter 110prior to use, will now be described in detail. With reference to FIGS.9A-11B, an exemplary cap 10 having the open proximal end 112 and aclosed distal end 114 is illustrated. The protective cap 10 isconfigured to be connected to the adapter housing via a snap fit. Forexample, the cap 10 can be configured to receive the distal end 118 ofthe housing 112 within a central cavity 16 as shown, for example, inFIGS. 11A and 11B. The protective cap 10 can be formed from a softerand/or more pliable material than the adapter, such as from soft rubberor pliable plastic. The cap 10 can be formed by injection molding or byanother suitable molding process, as is known in the art.

In some examples, the cap 10 includes an annular or main body 16 with aproximal portion 18 configured to engage a syringe adapter, a distalflange or base portion 20, and an annular sidewall 22 extendingtherebetween. In some examples, the flange or base portion 20 caninclude a substantially flat bottom surface 24 so that the cap 10 andsyringe adapter mounted thereto can be placed on a table or another flatsurface in a substantially upright position. In some examples, theannular sidewall 22 of the cap 10 can include a shoulder 26 (shown inFIG. 9B) disposed on a radially inner surface thereof. The shoulder 26can be an angled surface positioned to contact a portion of the distalend of the syringe adapter to provide additional support for theadapter.

Having described the general structure of the cap 10 and syringe adapter110, structures for mounting the cap 10 to the adapter 110 will now bedescribed in detail. As shown in FIGS. 11A and 11B, in some examples,the proximal portion 18 of the annular body 16 can be configured to formthe snap-fit engagement with an open distal end 118 of the syringeadapter 110. For example, the proximal portion 18 of the body 16 may beinwardly biased forming an axial interference engagement between the cap10 and adapter 110. In some examples, the proximal portion 18 of theannular body 16 may also include one or more protrusions or tabs 28configured to engage a portion of the distal end 118 of the housing 112to supplement the snap-fit engagement therebetween. In some examples,the second portion 140 of the adapter housing 112 may include one ormore recesses or protrusions positioned to engage the protrusions ortabs 28. For example, the second portion 140 can include an annulargroove or shelf 164 extending around the circumference thereofconfigured to contact the tabs 28 to from a suitable connectiontherewith. In other examples, the shelf 164 can be replaced with anumber of protrusions or detents extending from the outer surface of thesecond portion 140. The inwardly extending tabs 28 of the cap 10 can beconfigured to grasp (e.g., form a snap-fit engagement with) the shelf164 to restrict axial movement of the cap 10 relative to the syringeadapter 110. In some examples, the inwardly directed tabs 28 of the capannular body 16 can include two or more tabs 28 positioned about thecircumference of the proximal portion 18 of the annular body 16. A cap10 with a proximal portion 18 including four separate individual tabs 28positioned equidistantly around the circumference of the proximalportion 18 is shown, for example, in FIG. 9C. In other examples, asshown in FIG. 10, the proximal portion 18 of the annular body 16 caninclude an annular ring or lip 30 extending around the circumference ofthe proximal portion 18 of the cap annular body 16. The ring or lip 30can be configured to contact the shelf 164 (shown in FIGS. 11A and 11B)to form a suitable connection therebetween.

With reference to FIGS. 12A-12C, additional embodiments of a secondportion 140 of a syringe adapter 110 are illustrated showing alternativestructures for receiving and forming the snap fit with the protectivecap 10. For example, as shown in FIG. 12A, the second portion 140 caninclude a radially outwardly extending band or ridge 166 configured tocontact and engage a portion of a protective cap. As shown in FIG. 12B,in other examples, the second portion 140 can include an annular recessor groove 168 configured to receive a tab or annular ring. In stillother examples, as shown in FIG. 12C, the second portion 140 of theadapter 110 can include radially outwardly extending protrusions orbumps 170 configured to contact and engage portions of the cap to formthe snap-fit therewith. In any case, the cap 10 is designed to beremovable from the second portion 140. Accordingly, these interferencestructures, such as protrusions, grooves, or rings, should be sized torestrict removal of the cap from the syringe adapter 110 to preventinadvertent exposure of the needle. However, the protrusions, grooves,or rings should be small enough that the cap can be removed by the userwithout needing to exert unreasonable force or damaging the cap 10 oradapter 110.

Exemplary Protective Caps for Disinfecting the Syringe Adapter

In accordance with another aspect of the disclosure, a protective capcan be configured to permit the user to access the interior of thesyringe adapter to disinfect portions of the interior of the syringeadapter prior to use and, in particular, prior to removing the cap fromthe syringe adapter. An exemplary protective cap 210 which istransitionable between a closed position and an open position to permitaccess to the interior of a syringe adapter is shown in FIGS. 13A to15B. With reference to FIGS. 13A-14B, as in previously describedexamples, the cap 210 includes an open proximal end 212 configured to beconnected to an adapter housing via a snap fit. However, unlike in theother examples, the protective cap 210 also includes an open distal end214 for permitting access to the interior of the syringe adapter. Thecap 210 can include an annular or main body 216 with a proximal portion218 configured to engage a syringe adapter, a distal flange or baseportion 220, and an annular sidewall 222 extending therebetween. In someexamples, the flange or base portion 220 can include a substantiallyflat annular bottom surface 224 so that the cap 210 and syringe adaptermounted thereto can be placed on a table or another flat surface in asubstantially upright position. In some examples, the annular sidewall222 of the cap 210 can include a shoulder 226 (shown in FIG. 13B)disposed on a radially inner surface thereof. The shoulder 226 can be anangled surface positioned to contact a portion of the distal end of thesyringe adapter to provide additional support for the adapter.

The protective cap 210 may further include a retention member, such as atubular support 232, connected to and extending proximally from theflange or base portion 220 of the main body 216. The tubular support 232can be configured to be inserted into the open distal end 118 of thesyringe adapter 110 (shown in FIGS. 14A and 14B). The tubular support232 defines a central channel 234 extending between an open proximal end236 and an open distal end 238 thereof. As shown in FIGS. 13A and 13B,the tubular support 232 may have a circular cross-section configured tobe inserted in a corresponding circular open distal end 118 of thesyringe adapter 110. In other examples, the tubular support 232 can havedifferent cross-sectional shapes and/or dimensions depending on the sizeand shape of the open distal end 118 of the syringe adapter 110. Thetubular support 232 may extend a distance H1 beyond the proximal portion218 of the annular body 216 as shown in FIGS. 13A and 13B. In otherarrangements, the tubular support 232 may be the same height or may beshorter than the annular body 216 depending on the shape and structureof the syringe adapter 110.

With continued reference to FIGS. 13A to 14B, in some examples, theprotective cap 210 also includes a cover 240 connected to the baseportion 220 of the annular body 216. The cover 240 may be transitionablefrom a closed position (shown in FIGS. 13B and 14B) in which it coversthe distal open end 238 of the central channel 234 and an open position(shown in FIG. 15A and 15B) in which the channel 234 is uncovered,thereby allowing a user to access the interior 114 (shown in FIGS. 14Aand 14B) of the syringe adapter 110. When the cap 210 is in the openposition (shown in FIGS. 15A and 15B), a user can insert a swab throughthe open distal end 238 of the central channel 234 and open distal end118 of the syringe adapter 110 for disinfecting the interior 114 of thesyringe adapter 110. The cover 240 can be connected and/or mounted tothe base portion 220 of the annular body 216 by any type of connector orfastener suitable for forming a pivotal engagement or joint between thecover 240 and base portion 220. In one example, the cover 240 isintegrally formed with the base portion 220 of the annular body 216 andconnected together by a living hinge 242. A living hinge 242 can be athin flexible region (e.g., a bend line) between two more rigid portionsof a structure. A living hinge 242 can be formed by thinning or cuttinginto rigid pieces to form a bend line at a desired position between thetwo rigid pieces. Alternatively, a cap 210 including the thinned outliving hinge 242 can be formed during molding.

With continued reference to FIGS. 13A to 14B, in some examples, thecover 240 and/or base portion 220 of the annular body 216 can include alocking or latching mechanism for maintaining the cover 240 in theclosed position. For example, the cover 240 can include a proximallyextending lip including a detent 244 configured to engage acorresponding portion of the annular body 216. For example, the detent244 can be positioned to engage a corresponding projection or protrusion246 on the base portion 220 of the annular body 216 to form aninterference engagement therewith.

With specific reference to FIGS. 14A and 14B, as in previously describedexamples, the proximal portion 218 of the annular body 216 can beconfigured to form the snap-fit engagement with the open distal end 118of the syringe adapter 110. For example, the proximal portion 218 of thecap 210 may be inwardly biased forming an axial interference engagementbetween the cap 210 and the syringe adapter 110. In some examples, theproximal portion 218 of the annular body 216 may include one or moreprotrusions or tabs 228 configured to engage a portion of the distal end118 of the housing 112 to form the removable snap-fit engagementtherebetween. For example, as in previously described examples, thesecond portion 140 of the adapter housing 112 may include an annulargroove or shelf 164 extending around the circumference thereof.

As shown in FIG. 14A, when the cap 210 is mounted to the syringe adapter110, the tubular support 232 is inserted into the interior 114 of theadapter 110, such that the proximal open end 236 of the central channel234 extends up to or beyond the collet flange 134 and/or collet legs136. In this position, the outer surface of the tubular support 32 cancontact the flange 134 and/or legs 136 pressing the flange 134 and/orlegs 136 radially outwardly towards their recessed positions. Therefore,the tubular support 232 can hold the flange 134 and/or legs 136 awayfrom the central channel 234 of the tubular support 232 and the opendistal end 118 of the syringe adapter 110, such that they are notdisplaced when a swab is inserted into the adapter 110.

With reference to FIGS. 15A and 15B, steps for disinfecting the interior114 of the syringe adapter 110 will be described. As shown in FIG. 15A,a user, such as a clinician, can open the cover 240 by pulling a portionof the cover 240 away from the annular body 216 with sufficient force toovercome the latching mechanism engagement between the detent 244 andprotrusion 246. Once the interference engagement between the detent 244and protrusion 246 is overcome, the cover 240 swings in a downwarddirection as shown by arrow A1 to its open position. As discussedherein, the cover 240 can be connected to the annular body 216 by aflexible and/or pivoting joint, such as a living hinge 242. Accordingly,the cover 240 rotates or pivots about the joint or living hinge 242 fromthe closed position to the open position. Once the cover 240 is in itsopen position, the user advances a swab 248 containing a disinfectingagent toward the open distal end 118 of the adapter 110 in the directionof arrow A2 as shown in FIG. 15A. As shown in FIG. 15B, once the swab248 is inserted into the interior 114 of the adapter 110, the user maymove the swab in a radial fashion thereby contacting elements of theadapter interior and, in particular, elements of the sealing arrangement126. For example, the user may disinfect a distal surface of themembrane or septum 130 to ensure that the cannula 124 (shown in FIG. 3A)is not contaminated when it pierces the septum 130. Once disinfecting iscomplete, the user can remove the swab 248 from the interior 114 of thesyringe adapter 110 and close the cover 240 by swinging it back to itsclosed position in the direction of arrow A1 to prevent contamination ofthe interior 114 and/or septum 130. The closed position is illustrated,for example, in FIGS. 13B and 14A.

Exemplary Protective Cap Configured to be Inserted in the Open DistalEnd of the Syringe Adapter

With reference to FIGS. 16A and 16B, another exemplary embodiment of anassembly for connecting a syringe to a patient connector including thesyringe adapter 110 and a cap 310 is illustrated. The adapter 110 issubstantially similar to previously described adapters and includes thehousing 112 having a proximal end 116 configured to be mounted directlyor indirectly to the syringe and an open distal end 118 configured to beremovably mounted to the protective cap 310. The cap 310 includes anannular body 316 having a proximal portion 318 extending from a flangeor base portion 320. Unlike in previously described examples in whichthe open distal end 118 of the adapter 110 is inserted into the annularbody of the cap, for the cap 310, the proximal portion 318 of the body316 can be sized and shaped to be inserted into the distal open end 118of the syringe adapter 110 to mount the syringe adapter 110 to the cap310. For example, the proximal portion 318 of the annular body 316 maybe slightly larger (e.g., have a slightly larger diameter) than thedistal open end 118 of the syringe adapter 110, such that when insertedinto the open distal end 118 of the adapter 110, a frictional engagementbetween the cap 310 and adapter 110 is formed. As in previouslydescribed examples, the cap 310 can be formed from a soft flexibleand/or elastomeric material such that it deforms slightly when insertedinto the adapter 110. The resiliency of the cap 310 can contribute tothe frictional engagement between the adapter 110 and the cap 310. Theproximal portion 318 of the annular body 316 can also include a flangeor lip 350 (shown in FIG. 16B) configured to contact the open distal end118 of the adapter 110 to restrict or prevent a user from pulling thecap 310 from the adapter 110. As in previously described examples, thecap 310 can also include a cover 340 connected to the base portion 320of the annular body 316. The cover 340 can be transitionable from aclosed position in which it covers a distal open end 338 of the annularbody 316, and an open position in which a swab is capable of beinginserted through the open end 338 and open distal end 118 of the syringeadapter 110 for disinfecting the interior 114 of the syringe adapter110.

Exemplary Protective Cap with Swab or Pad

With reference to FIGS. 17A and 17B, another exemplary embodiment of acap 410 for a syringe adapter 110 (shown in FIG. 17B) is illustrated. Asin previously described examples, the cap 410 includes an annular body416 having a proximal portion 418 configured to engage the syringeadapter 110, a distal base portion 420, and an annular sidewall 422extending therebetween. As in previously described examples, the cap 410also includes a retention member, such as a tubular support 432,connected to and extending proximally from the base portion 420 of theannular body 416. The tubular support 432 can include or define acentral channel 434 extending between an open proximal end 436 and aclosed distal end 438 thereof. Unlike in previously described examples,in which the cap is configured to permit a user to insert a swab intothe interior of the adapter 110, the cap 410 includes a swab or pad 452mounted within the central channel 434 of the tubular support 432. Theswab or pad 452 can be formed from an absorbent material, such as cottonor other types of absorbent fibers. The swab or pad 452 can be wettedwith a disinfecting solution, such as isopropyl alcohol, fordisinfecting the interior 114 of the adapter 110. For example, the swabor pad 452 can be used to disinfect a distal surface of the membrane orseptum 130 (shown in FIG. 17B). As shown in FIG. 17B, when the cap 410is mounted to the syringe adapter 110, the outer surface of the tubularsupport 432 contacts the collet flange 134 and collet legs 136 tomaintain the flange 134 and legs 136 in their recessed positions. Theswab or pad 452 protrudes beyond the open proximal end 436 of thecentral cavity 434 of the tubular support 432 into the interior 114 ofthe adapter 110. For example, a proximal end of the swab or pad 452 cancome into face-to-face contact with the membrane or septum 130 todisinfect the septum 130. Disinfecting the septum 130 prior toactivation of the adapter 110 can prevent or reduce contamination of theneedle cannula 124 (shown in FIG. 2A), which pierces the septum 130.When ready to connect the adapter 110 to the patient connector, the userremoves the cap 410, such as by pulling the cap 410 in a distaldirection D with sufficient force to overcome an axial interferenceengagement between the cap 410 and distal end 118 of the adapter 110,thereby exposing the open distal end 118 of the adapter 110. Once thecap 410 is removed, the user can insert a portion of the patientconnector through the open distal end 118 of the adapter 110. The flange134 and/or legs 136 of the collet 128 grasp the inserted portion of thepatient connector to form a suitable engagement therebetween. Theadapter 110 can then be activated in the manner described herein, bymoving the collet 128 in a proximal direction, thereby causing thecannula 124 to pierce the septum 130 and engage the patient connector(not shown).

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred aspects, it is to be understood that such detailis solely for that purpose and that the invention is not limited to thedisclosed aspects, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any aspect can be combined with one or more features ofany other aspect.

The invention claimed is:
 1. A syringe adapter comprising: a housinghaving a first end and a second end positioned opposite the first end,the first end of the housing having a connector configured to be securedto a syringe barrel; a cannula positioned within the housing; a sealarrangement positioned within the housing and movable within thehousing, the seal arrangement comprising a membrane; and a protectivecap having a first open end and a second closed end, the protective capbeing connected to the housing via a snap fit and receiving the secondend of the housing.
 2. The syringe adapter of claim 1, wherein theprotective cap comprises an annular ring extending radially inward, andwherein the housing defines one or more recesses or protrusionspositioned to engage the annular ring to form the snap fit.
 3. Thesyringe adapter of claim 1, wherein the protective cap comprises one ormore projections extending radially inward, and wherein the one or moreprojections of the protective cap are positioned to engage one or morerecesses or protrusions of the housing to form the snap fit.
 4. Thesyringe adapter of claim 1, wherein the protective cap comprises a mainbody and a flange extending radially outward from the main body of theprotective cap.
 5. The syringe adapter of claim 4, wherein the main bodycomprises an annular shoulder on a radially inward side thereof, andwherein the second end of the housing contacts the shoulder when theadapter is mounted to the cap.
 6. A syringe adapter comprising: ahousing having a first end and a second end positioned opposite thefirst end, the first end of the housing having a connector configured tobe secured to a syringe barrel; a cannula positioned within the housing;a seal arrangement positioned within the housing and movable within thehousing, the seal arrangement comprising a membrane; and a protectivecap having a first open end and a second end positioned opposite thefirst end, the protective cap having a restriction member configured toengage a portion of the seal arrangement to prevent movement of the sealarrangement within the housing.
 7. The syringe adapter of claim 6,wherein the restriction member comprises a tubular support extendingproximally from a base portion of the protective cap, the tubularsupport comprising a central channel extending between the open firstend and the open second end of the protective cap.
 8. The syringeadapter of claim 6, wherein the second end of the protective capcomprises a removable cover having an open position and a closedposition.
 9. The syringe adapter of claim 8, wherein when the removablecover is in the open position, a portion of the membrane of the sealarrangement is accessible via the second end of the protective cap. 10.The syringe adapter of claim 9, wherein when the removable cover is inthe closed position, the membrane of the seal arrangement isinaccessible via the second end of the protective cap.
 11. The syringeadapter of claim 8, wherein the removable cover comprises a living hingeto allow the removable cover to move between the open position and theclosed position.
 12. The syringe adapter of claim 8, wherein theremovable cover further comprises a protruding latch configured toengage a radially outer portion of the protective cap to maintain thecover in the closed position.
 13. The syringe adapter of claim 12,wherein the removable cover comprises a first end pivotally connected tothe protective cap and a second end opposite the first end, and whereinthe latch extends from the second end of the cover.
 14. The syringeadapter of claim 8, wherein, when in the open position, a swab iscapable of being inserted through the open distal end of the protectivecover for disinfecting at least a portion of the seal arrangement. 15.The syringe adapter of claim 6, wherein the seal arrangement comprises acollet that receives the membrane, the restriction member engages aportion of the collet to restrict radial movement of the collet therebypreventing movement of the collet within the housing.
 16. The syringeadapter of claim 6, wherein the protective cap is connected to thehousing via a snap fit and receives the second end of the housing. 17.The syringe adapter of claim 16, wherein the protective cap comprises anannular ring extending radially inward, and wherein the housing definesone or more recesses or protrusions, and wherein the annular ring of theprotective cap engages the one or more recesses or protrusions to formthe snap fit.
 18. The syringe adapter of claim 16, wherein theprotective cap comprises one or more projections extending radiallyinward, and wherein the housing defines one or more recesses orprotrusions, and wherein the one or more projections of the protectivecap engage the one or more recesses or protrusions of the housing toform the snap fit.
 19. The syringe adapter of claim 6, wherein theprotective cap comprises a main body and a flange extending radiallyoutward from the main body of the protective cap.
 20. The syringeadapter of claim 6, wherein the restriction member comprises a tubularbody, the tubular body of the restriction member receiving adisinfecting pad.
 21. A protective cap configured to be removablymounted to a syringe adapter, the cap comprising: an annular bodycomprising a proximal portion configured to engage the syringe adapter,a distal base portion, and an annular sidewall extending therebetween; arestriction member connected to and extending proximally from the baseportion of the annular body, the restriction member comprising a centralchannel extending between an open proximal end and an open distal endthereof; and a cover connected to the base portion of the annular body,wherein the cover is transitionable from a closed position in which itcovers the distal open end of the central channel, and an open positionin which a swab is capable of being inserted through the open distal endof the central channel for disinfecting an interior of the syringeadapter.